Allovectin-7 is a gene-based immunotherapy for certain types of cancer. The therapy is designed to train the body's immune system to recognize and destroy tumor cells. The phase 3 study will determine if Allovectin-7 is more effective than standard chemotherapy for treating people with advanced melanoma.

"Melanoma, like many types of cancer, is often successful at keeping the body from attacking it," said Dr. Michael Warso, associate professor of surgical oncology at UIC and an investigator on the study. "One of the goals of treatment is to change things so the body can identify and attack the melanoma. We believe that Allovectin-7 triggers several of the body's natural immune response mechanisms to recognize and attack the tumors, both locally and throughout the body."

To be eligible for the study, patients must be at least 18 years old and have confirmed recurrent metastatic melanoma with at least one tumor large enough to inject -- about the size of a pea. Patients who have received previous chemotherapy for melanoma are ineligible. In addition, patients with lung lesions can be included, but those with liver or brain lesions cannot.

Approximately 375 patients nationwide will be enrolled to receive either Allovectin-7 alone or the current standard chemotherapy (dacarbazine or temozolomide) alone. Two thirds of enrolled patients will be randomly assigned to receive Allovectin-7 and the remaining third will receive chemotherapy.

Allovectin-7 will be administered by a weekly injection into the tumor for six consecutive weeks. The injection cycle may be repeated every eight weeks. Participants will be closely monitored to assess disease status, treatment safety and tolerability. Patients whose melanoma does not worsen will be encouraged to continue on the treatment and be assessed for up to two years.

Warso said the investigational agent can be given on an outpatient basis and has been safe and well-tolerated in clinical trials to date.

Melanoma is among the fastest-growing cancer indications, rising at a 3 percent to 5 percent annual rate over the last 30 years. The American Cancer Society estimates that in 2007 about 60,000 new cases of melanoma will be diagnosed in the United States and over 8,000 patients will die. The exact cause of melanoma is not always clear, but exposure to ultraviolet radiation from sunlight is a major risk factor. Melanoma is more likely to occur in those having fair skin, a large number of moles, a history of sun tanning or sunburns, or close relatives with the disease.

Patients whose melanoma is caught early can often be cured with surgery. However, advanced melanoma that has spread beyond the original site to other parts of the body usually requires additional treatment, such as chemotherapy. Because cures at this stage are rare, therapy for late-stage melanoma has been focused on reducing the tumor burden and increasing a patient's length of survival. Standard chemotherapy produces poor long-lasting response rates and often presents serious side effects.

"My patients are looking for the best treatment options available to them," Warso said. Although it is optimal to catch cancer before it progresses, he said, many melanoma patients are first diagnosed after the disease has spread to other organs.

Allovectin-7 is a registered trademark of Vical Incorporated, which developed the investigational agent and is funding the trial.

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